A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

ClinicalTrials.gov ID: NCT00505414

Public ClinicalTrials.gov record NCT00505414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 11:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.

Study identification

NCT ID: NCT00505414
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Grünenthal GmbH; Industry
Enrollment: 136 participants

Conditions and interventions

Conditions

Interventions

Tapentadol in the Titration Phase Drug
Morphine in the Maintenance Phase Drug
Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase Drug
Tapentadol in the Maintenance Phase Drug
Morphine in the Titration Phase Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 31, 2007
Primary completion: Jan 31, 2009
Completion: Apr 30, 2009
Last update posted: Oct 31, 2019

2007 – 2009

United States locations

U.S. sites: 7
U.S. states: 6
U.S. cities: 7

Facility	City	State	ZIP	Site status
001013	St. Petersburg	Florida	80918	—
001002	Elkhart	Indiana	46514	—
001001	Shreveport	Louisiana	71103	—
001010	Cedarhurst	New York	11516	—
001003	Glens Falls	New York	12801	—
001004	Winston-Salem	North Carolina	27103	—
001015	Canton	Ohio	44718	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00505414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 31, 2019 · Synced Jul 23, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00505414 live on ClinicalTrials.gov.

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